Coordinated Oral Health Promotion (CO-OP) Chicago

October 13, 2022 updated by: Molly A. Martin, University of Illinois at Chicago
This study assesses the impact of oral health promotion delivered by community health workers in medical clinics, Women, Infants and Children (WIC) centers, and family homes. Investigators will assess oral health behaviors in children aged 0 to 3.

Study Overview

Detailed Description

Dental caries is the most common chronic disease of childhood; an estimated 28% of children nationally aged 5 years and below have untreated dental disease. Pediatric dental caries are associated with pain, more severe infections, malnutrition, speech difficulties, poor school performance, cosmetic problems, and an overall lower quality of life. Similar to other chronic diseases, oral health disparities are seen with higher caries prevalence and worse outcomes in children from low income urban families and in children of African American and Latino ethnicity. These disparities have been demonstrated locally in Chicago. Many interventions have been implemented to attempt to reverse these disparities. Some involve public policy (fluorinated water), some are educational campaigns targeting individuals, while others focus on providing increased education and services through primary healthcare providers. Many of these programs have demonstrated efficacy but the disparities in oral health persist. The investigators propose this is because the interventions to date do not target the family as a whole and also have not targeted multiple levels simultaneously.

COordinated Oral health Promotion (CO-OP) Chicago brings together a team of clinical pediatricians and dentists, health researchers, and policy experts to rigorously test the ability of multiple oral health promotion interventions, both alone and in combination, to improve child and family oral health. The primary intervention is family-focused education and support from community health workers (CHWs). CO-OP Chicago will test the impact of a family-focused CHW intervention for oral health promotion when applied in clinical, community, and home settings. The primary study objective is to evaluate the efficacy of a one-year oral health CHW intervention, compared to usual care, to improve self-reported brushing frequency and observed plaque score in low income urban children under the age of 3 years old. The study's exploratory aim is to determine if the oral health CHW intervention impact on child tooth brushing behaviors varies when the CHWs are based out of a medical clinic compared to a community WIC center.

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Blue Island, Illinois, United States, 60406
        • CEDA WIC Center Blue Island
      • Chicago, Illinois, United States, 60604
        • Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)
      • Chicago, Illinois, United States, 60608
        • Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago Outpatient Care Center
      • Chicago, Illinois, United States, 60617
        • Aunt Martha's Southeast Side Community Health Center
      • Chicago, Illinois, United States, 60629
        • Vida Pediatrics
      • Chicago, Illinois, United States, 60661
        • CEDA WIC Centers (Diversey, Irving Park)
      • Chicago Heights, Illinois, United States, 60411
        • Aunt Martha's Pediatric Health & Wellness Center
      • Harvey, Illinois, United States, 60426
        • CEDA WIC Center Harvey
      • Maywood, Illinois, United States, 60153
        • CEDA WIC Center Maywood
      • Oak Park, Illinois, United States, 60304
        • CEDA WIC Oak Park
      • South Holland, Illinois, United States, 60473
        • Aunt Martha's South Holland Community Health Center
      • Summit, Illinois, United States, 60501
        • CEDA WIC Summit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Caregiver:

  • Provide a signed and dated informed consent form
  • Age 18 or older
  • Be the primary caregiver of a child age 6-36 months old. The primary caregiver is defined for this study as the person (or one of the people) who is consistently responsible for the child's daily routines and who is a legal guardian.
  • If a child lives in multiple households, the caregiver must live with the child at least 5 days of the week.
  • The child must be an active patient/client in the clinic/center where recruited.
  • Speak English or Spanish
  • Willing to comply with all study procedures and be available for the duration of the study

Child:

  • Age 6-36 months old
  • An active patient/client in the clinic/center where recruited
  • A minimum of two fully erupted central maxillary incisors

Exclusion Criteria:

  • Child with medical condition that limits his or her ability to conduct the study activities (such as severe developmental or cognitive delay, ventilator or oxygen dependence, oral aversion, severe facial deformities)
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
  • Anything that would place the research or intervention staff at increased risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHW Arm
The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family.
CHWs are non-clinical people who provide education, care coordination, and support to families.
No Intervention: Wait-list Control Arm
This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-reported Tooth Brushing Frequency
Time Frame: 12-months post-randomization
parents will be asked how often the child's teeth are brushed
12-months post-randomization
Child Dental Plaque Score
Time Frame: 12-months post-randomization
Disclosing solution is applied to child's teeth, images are taken, and plaque score is determined using the Oral health Index - Maxillary Incisor Score (OHI-MIS). The buccal surfaces of teeth #D, E, F, and G were scored from 0-3, with 3 being the worst (plaque on more than 2/3 of tooth surface) and 0 being the best (no plaque present). The four individual tooth scores (or less if child did not have four teeth) were then added and divided by the number of teeth for a final average score ranging from 0-3.
12-months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2018

Primary Completion (Actual)

August 20, 2020

Study Completion (Actual)

August 20, 2020

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-1090
  • UH3DE025483 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Three years after the end of the CO-OP Chicago research activity, data will be publicly released. Data will be maintained by the study team, in partnership with the community clinical partner. Registration will be required to access or download data files. Registered users will receive technical assistance with questions or problems from the Methodology Research Core (MRC) at the University of Illinois at Chicago's Institute for Health Research and Policy or from the UCSF Coordinating Center. A data sharing agreement will be required that will describe the conditions and restrictions of their use; limited data access will be made available only to users who successfully complete a rigorous approval process by both the investigators and the community partners. Data sets will be encrypted for transfer to approved investigators.

IPD Sharing Time Frame

These details are not fully developed.

IPD Sharing Access Criteria

These details are not fully developed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries in Children

Clinical Trials on Community Health Worker (CHW) services

Subscribe